Ignite Creation Date:
2025-12-18 @ 8:13 AM
Ignite Modification Date:
2025-12-23 @ 6:13 PM
Study NCT ID:
NCT01928524
Status:
None
Last Update Posted:
2021-02-16 00:00:00
First Post:
2013-08-21 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemotherapy for Patients With Cancer of the Stomach
Sponsor:
None
Organization:
Study Overview
Official Title:
Phase I Trial With Docetaxel, Oxaliplatin and S1 as First-line Treatment for Patients With Non-resectable Adenocarcinoma of the Esophagus or Gastric
Status:
None
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOS
Brief Summary:
The primary aim of this dose-finding study is to determine the maximum tolerated doses of docetaxel, oxaliplatin and S1 given every second (DOS2w) or third (DOS3w) week as first-line treatment in patients with advanced gastro-esophageal cancer. Secondary end points are to evaluate toxicities according to NCI-CTCAE v. 4, response rate, progression-free survival and overall survival
Primary Outcome Measure:
To determine maximum tolerated dose (MTD) for the the combination regimes (DOS2w) and (DOS3w).
The investigators have planned to examine 4 dose levels of (DOS2w) and 3 dose levels of (DOS3w).
Methods:
This dose-finding study is planned to include a total of 24 patients with advanced gastro-esophageal cancer, adenocarcinoma.
12 patients will be included in (DOS2w) at four at progressively higher dose levels.
Chemotherapy will be repeated day 1 every second week to a maximum of nine courses.
12 patients will be included in (DOS3w) at three progressively higher dose levels.
Chemotherapy will be repeated day 1 every third week to a maximum of six courses.
In both (DOS2w) and (DOS3w) dose-limiting toxicity (DLT) will be evaluated after the first course. In case of DLT among one of the three patients during the first course of treatment additional three patients will be added at the respective dose level. Dose escalation is continues if 0/3 or 1/6 patients experience DLT.
Patients will be evaluated with a ct-scan at baseline and after every three or four cycles to exclude progression and evaluate response. Response is assessed by the investigator according to RECIST version 1.1.
Primary Outcome Measure:
To determine maximum tolerated dose (MTD) for the the combination regimes (DOS2w) and (DOS3w).
The investigators have planned to examine 4 dose levels of (DOS2w) and 3 dose levels of (DOS3w).
Methods:
This dose-finding study is planned to include a total of 24 patients with advanced gastro-esophageal cancer, adenocarcinoma.
12 patients will be included in (DOS2w) at four at progressively higher dose levels.
Chemotherapy will be repeated day 1 every second week to a maximum of nine courses.
12 patients will be included in (DOS3w) at three progressively higher dose levels.
Chemotherapy will be repeated day 1 every third week to a maximum of six courses.
In both (DOS2w) and (DOS3w) dose-limiting toxicity (DLT) will be evaluated after the first course. In case of DLT among one of the three patients during the first course of treatment additional three patients will be added at the respective dose level. Dose escalation is continues if 0/3 or 1/6 patients experience DLT.
Patients will be evaluated with a ct-scan at baseline and after every three or four cycles to exclude progression and evaluate response. Response is assessed by the investigator according to RECIST version 1.1.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: